HealthyPhase 1NCT07542886
A Study to Learn How Different Injector Pens Affect the Study Medicine Called Genotropin (Somatropin) Delivery and Taken up Into the Blood in Healthy Adults
A Phase 1 study testing Marketed Genotropin Pen 12, New Genotropin Injector Pen and Genotropin 4mg in people with Healthy, run by Pfizer at 1 site in Belgium.
Trial summary
The purpose of this clinical study is to learn about how different injector pens affect: how the study medicine (called Genotropin) is delivered into the body and how the study medicine is taken up into the blood in healthy adults. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Marketed Genotropin Pen 12, New Genotropin Injector Pen and Genotropin 4mg
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteBelgium
- Study dates
- 22 Apr 2026to 24 Jul 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Participants
- BMI 16 to 32 kg/m2
- body weight more than 45kg
Who cannot join
- Ongoing or past history of significant medical conditions
- Use of prescription or non prescription medications within 14 days of first study dose
- Previous exposure to growth hormone
- History of alcohol abuse, binge drinking or illicit drug use
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Pfizer Clinical Research Unit - Brussels
Brussels, Bruxelles-capitale, Région de, B-1070
About this study
Official title: A PHASE 1, OPEN-LABEL, RANDOMIZED, SINGLE-DOSE, CROSSOVER STUDY TO EVALUATE THE BIOEQUIVALENCE OF TWO DIFFERENT INJECTOR PEN DEVICES FOLLOWING SUBCUTANEOUS ADMINISTRATION OF THE SAME GENOTROPIN® (SOMATROPIN) DOSE IN HEALTHY ADULT PARTICIPANTS
The purpose of this clinical study is to learn about how different injector pens affect:
- how the study medicine (called Genotropin) is delivered into the body and
- how the study medicine is taken up into the blood in healthy adults.
Read more
The study is seeking participants who are:
- Aged 18 to 60 years old
- Male or female who are healthy as determined by medical assessment
- Body-mass index (BMI) of 16 to 32, and a total body weight more than 45 kg. BMI is a way to estimate a healthy body weight for an adult's height.
Adults in this study will receive study medicine by a shot under the skin. The study medicine will be given using 2 different injector pens which are medical devices that give a shot under the skin. Blood samples will be taken before and after the shots to look for the study medicine. We will compare the amount of study medicine in the blood between shots from the 2 injector pens.
Adults will take part in this study for about 10 weeks including the screening period. They will have to stay at the study clinic for at least 13 days. This includes 2 study periods in total. A follow up phone call will be made 23 to 30 days following the last study period.
- Conditions
- Healthy
- Being tested
- Marketed Genotropin Pen 12, New Genotropin Injector Pen, Genotropin 4mg
- Keywords
- bioequivalence, genotropin, adult
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Marketed Genotropin Pen 12Device
Growth Hormone Delivery Device for use with Somatropin for injection
New Genotropin Injector PenDevice
Growth Hormone Delivery Device for use with Somatropin for injection
Genotropin 4mgDrug
Also called Somatropin
4mg subcutaneous
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Experimental | Single dose of 4 milligrams (mg) subcutaneous genotropin via marketed genotropin pen 12 (Reference) followed by single dose of 4mg subcutaneous genotropin via new genotropin injector pen (Test) Receives: Device: Marketed Genotropin Pen 12; Device: New Genotropin Injector Pen; Drug: Genotropin 4mg |
| Sequence 2 | Experimental | Single dose of 4mg subcutaneous genotropin via new genotropin injector pen (Test) followed by single dose of 4mg subcutaneous genotropin via marketed genotropin pen 12 (Reference) Receives: Device: Marketed Genotropin Pen 12; Device: New Genotropin Injector Pen; Drug: Genotropin 4mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinity (AUCinf) of Somatropin
AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0-t) plus AUC (t-inf).
Measured: At pre-dose -24, -18, -12, -8, 0 and 1, 2, 3, 4, 6, 8, 10, 12, 16 and 24 hours post-dose on day 1 of each period
Maximum Observed Plasma Concentration (Cmax) for Somatropin
Measured: At pre-dose -24, -18, -12, -8, 0 and 1, 2, 3, 4, 6, 8, 10, 12, 16 and 24 hours post-dose on day 1 of each period
Secondary outcomes (4)
Number of Participants With Treatment Emergent Adverse Events
Measured: From start of study treatment up to 28-35 days after last dose of study treatment (41 days)
Number of Participants With Clinical Laboratory Abnormalities
Measured: Up to Day 11
Area under the effect-time curve from 0 to time of last measurable concentration (AUEClast)
Area under the effect-time curve to the last observed time point of Serum IGF-1
Measured: At pre-dose and 6, 12, 24, 48, 72 and 96 hours post-dose on day 1 of each period
Maximum observed effect (Emax)
Maximum observed effect of Serum IGF-1
Measured: At pre-dose and 6, 12, 24, 48, 72 and 96 hours post-dose on day 1 of each period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2026
- Study start22 Apr 2026
- Primary completion25 Jun 2026
- Study completion24 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07542886
- Sponsor's protocol ID
- A6281331
- Other IDs
- 2026-525165-52-00
- Status last verified
- Aug 2026
- First submitted
- 14 Apr 2026
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE 1, OPEN-LABEL, RANDOMIZED, SINGLE-DOSE, CROSSOVER STUDY TO EVALUATE THE BIOEQUIVALENCE OF TWO DIFFERENT INJECTOR PEN DEVICES FOLLOWING SUBCUTANEOUS ADMINISTRATION OF THE SAME GENOTROPIN® (SOMATROPIN) DOSE IN HEALTHY ADULT PARTICIPANTS
- ClinicalTrials.gov ID
- NCT07542886
- Acronym / sponsor ID
- A6281331
- Conditions
- Healthy
- Keywords
- bioequivalence, genotropin, adult
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 22 Apr 2026 (actual)
- Primary completion
- 25 Jun 2026 (actual)
- Study completion
- 24 Jul 2026 (actual)
- First posted
- 21 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this clinical study is to learn about how different injector pens affect:
- how the study medicine (called Genotropin) is delivered into the body and
- how the study medicine is taken up into the blood in healthy adults.
The study is seeking participants who are:
- Aged 18 to 60 years old
- Male or female who are healthy as determined by medical assessment
- Body-mass index (BMI) of 16 to 32, and a total body weight more than 45 kg. BMI is a way to estimate a healthy body weight for an adult's height.
Adults in this study will receive study medicine by a shot under the skin. The study medicine will be given using 2 different injector pens which are medical devices that give a shot under the skin. Blood samples will be taken before and after the shots to look for the study medicine. We will compare the amount of study medicine in the blood between shots from the 2 injector pens.
Adults will take part in this study for about 10 weeks including the screening period. They will have to stay at the study clinic for at least 13 days. This includes 2 study periods in total. A follow up phone call will be made 23 to 30 days following the last study period.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Experimental | Device: Marketed Genotropin Pen 12, Device: New Genotropin Injector Pen, Drug: Genotropin 4mgSingle dose of 4 milligrams (mg) subcutaneous genotropin via marketed genotropin pen 12 (Reference) followed by single dose of 4mg subcutaneous genotropin via new genotropin injector pen (Test) |
| Sequence 2 | Experimental | Device: Marketed Genotropin Pen 12, Device: New Genotropin Injector Pen, Drug: Genotropin 4mgSingle dose of 4mg subcutaneous genotropin via new genotropin injector pen (Test) followed by single dose of 4mg subcutaneous genotropin via marketed genotropin pen 12 (Reference) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy Participants
- BMI 16 to 32 kg/m2
- body weight more than 45kg
Key exclusion criteria (4 listed)
- Ongoing or past history of significant medical conditions
- Use of prescription or non prescription medications within 14 days of first study dose
- Previous exposure to growth hormone
- History of alcohol abuse, binge drinking or illicit drug use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Marketed Genotropin Pen 12Growth Hormone Delivery Device for use with Somatropin for injection | Device | Sequence 1, Sequence 2 |
| New Genotropin Injector PenGrowth Hormone Delivery Device for use with Somatropin for injection | Device | Sequence 1, Sequence 2 |
| Genotropin 4mgAlso: Somatropin4mg subcutaneous | Drug | Sequence 1, Sequence 2 |
Primary outcome
Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinity (AUCinf) of Somatropin
Time frame: At pre-dose -24, -18, -12, -8, 0 and 1, 2, 3, 4, 6, 8, 10, 12, 16 and 24 hours post-dose on day 1 of each period
AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0-t) plus AUC (t-inf).
Maximum Observed Plasma Concentration (Cmax) for Somatropin
Time frame: At pre-dose -24, -18, -12, -8, 0 and 1, 2, 3, 4, 6, 8, 10, 12, 16 and 24 hours post-dose on day 1 of each period
4 secondary outcomes
Number of Participants With Treatment Emergent Adverse Events
Time frame: From start of study treatment up to 28-35 days after last dose of study treatment (41 days)
Number of Participants With Clinical Laboratory Abnormalities
Time frame: Up to Day 11
Area under the effect-time curve from 0 to time of last measurable concentration (AUEClast)
Time frame: At pre-dose and 6, 12, 24, 48, 72 and 96 hours post-dose on day 1 of each period
Maximum observed effect (Emax)
Time frame: At pre-dose and 6, 12, 24, 48, 72 and 96 hours post-dose on day 1 of each period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Marketed Genotropin Pen 12, New Genotropin Injector Pen and Genotropin 4mg in people with Healthy, run by Pfizer at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinity (AUCinf) of Somatropin (time frame: At pre-dose -24, -18, -12, -8, 0 and 1, 2, 3, 4, 6, 8, 10, 12, 16 and 24 hours post-dose on day 1 of each period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.